Aktuelle Jobs im Zusammenhang mit Regulatory Affairs and Quality Management Lead - Hamburg, Hamburg - apoqlar
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Regulatory Affairs and Quality Management Lead
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and Quality Management LeadAt apoQlar, we're revolutionizing the healthcare industry with cutting-edge medical mixed reality technology. As a Regulatory Affairs and Quality Management Lead, you'll play a crucial role in ensuring our platform meets regulatory and statutory requirements.About the Role:Develop and lead the...
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Regulatory Affairs and Quality Management Lead
vor 3 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
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Regulatory Affairs and Quality Management Lead
vor 3 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
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Regulatory Affairs and Quality Management Lead
vor 4 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
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Regulatory Affairs and Quality Management Lead
vor 4 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
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Regulatory Affairs and Quality Management Lead
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:Apoqlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the healthcare industry. Our flagship product, VSI HoloMedicine, is a medically certified software...
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Regulatory Affairs and Quality Management Lead
vor 1 Monat
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
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Regulatory Affairs and Quality Management Lead
vor 1 Monat
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
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Regulatory Affairs and Quality Management Lead
vor 1 Woche
Hamburg, Hamburg, Deutschland apoqlar VollzeitTransforming Healthcare with Medical Mixed RealityAbout Us:Apoqlar is a pioneering developer of medical mixed reality technology, revolutionizing the healthcare industry with cutting-edge solutions. Our flagship product, VSI HoloMedicine, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform medical images,...
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Regulatory Affairs and Quality Management Lead
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitTransforming Healthcare with Cutting-Edge TechnologyApoqlar is a pioneering medical technology company that is revolutionizing the healthcare industry with its innovative mixed reality platform. We are seeking a highly skilled Regulatory Affairs and Quality Management Lead to join our team in Hamburg.About the RoleThe successful candidate will be responsible...
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Regulatory Affairs and Quality Management Lead
vor 1 Woche
Hamburg, Hamburg, Deutschland apoqlar VollzeitMake a Positive Impact in the Global Healthcare CommunityAbout Us: apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform...
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Regulatory Affairs and Quality Management Lead
vor 1 Woche
Hamburg, Hamburg, Deutschland apoqlar VollzeitMake a Positive Impact in the Global Healthcare CommunityAbout Us: apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform...
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Hamburg, Hamburg, Deutschland apoqlar VollzeitTransformative Opportunity in Medical Mixed RealityAbout Us: apoQlar is a pioneering developer of a medical mixed reality platform that is revolutionizing healthcare practices, education, and experiences. Our flagship product, VSI HoloMedicine, is a medically certified software platform leveraging the Microsoft HoloLens hardware to transform medical images,...
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Regulatory Affairs and Quality Management Expert
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitTransform the Future of Healthcare with apoQlarAbout Us:ApoQlar is a pioneering medical technology company that is revolutionizing the healthcare industry with its cutting-edge medical mixed reality platform, VSI HoloMedicine. Our platform leverages the Microsoft HoloLens hardware to transform medical images, clinical workflows, and medical education into an...
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Regulatory Affairs Director
vor 2 Wochen
Hamburg, Hamburg, Deutschland Olympus VollzeitJob SummaryOlympus is seeking an experienced Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key Responsibilities:Lead and manage...
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Regulatory Affairs Director
vor 1 Woche
Hamburg, Hamburg, Deutschland Olympus VollzeitJob SummaryOlympus is seeking an experienced Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key Responsibilities:Lead and manage...
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Regulatory Affairs Director
vor 1 Woche
Hamburg, Hamburg, Deutschland Olympus VollzeitKey Responsibilities:We are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key...
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Senior Regulatory Affairs Manager
vor 3 Wochen
Hamburg, Hamburg, Deutschland Olympus VollzeitJob SummaryWe are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key...
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Senior Regulatory Affairs Manager
vor 1 Monat
Hamburg, Hamburg, Deutschland Olympus VollzeitAbout the RoleWe are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key...
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Senior Regulatory Affairs Manager
vor 1 Monat
Hamburg, Hamburg, Deutschland Olympus VollzeitAbout the RoleWe are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key...
Regulatory Affairs and Quality Management Lead
vor 2 Monaten
We are seeking a highly skilled Regulatory Affairs and Quality Management Lead to join our team at apoQlar. As a key member of our Regulatory & Quality Management team, you will play a leading role in ensuring our medical mixed reality platform is in compliance with regulatory and statutory requirements.
Key Responsibilities- Develop and Lead Regulatory Strategy: Ensure compliance with applicable laws, regulations, and facilitate fast and efficient certification of new product developments.
- Maintain and Optimize QMS: Focus on specific processes such as change control, design controls, verification and validation, and risk management.
- Lead Regulatory Approval Processes: Globally coordinate and lead the regulatory approval processes.
- Develop Regulatory Responses: Create regulatory responses for questions from notified bodies, global regulators, and regulatory representatives.
- Implement Regulatory Requirements: Ensure compliance with EU MDR 2017/745.
- Lead Risk Management Activities: Collaborate with the risk management team through the life cycle of medical device software.
- Participate in Audits: Support external and internal audits and respond to audit findings.
- Ensure Compliance: Ensure compliance with current regulatory procedures and update procedures as needed.
- Monitor Regulatory Requirements: Stay up-to-date with new and revised applicable regulatory requirements, standards, guidance, and common specifications.
- Handle Serious Incidents: Report and handle serious incidents and adverse events.
- Effective Communication: Ensure effective communication with Notified Bodies and Regulatory Authorities.
- Marketing Compliance: Ensure marketing communication is in accordance with regulatory requirements.
- Regulatory Awareness: Promote awareness of applicable regulatory requirements throughout the organization.
- PRRC: Act as the appointed Person Responsible for Regulatory Compliance.
- University Degree: In biomedical science, engineering, pharmacy, or any other applied natural sciences.
- Professional Experience: 7+ years of experience including MDD/MDR and FDA submissions.
- Practical Knowledge: Proficient practical FDA 510K application knowledge and a proven track record of associated products.
- Regulatory Knowledge: Proficient knowledge of EU medical device regulations and Quality Management Systems for medical devices.
- Software Knowledge: In-depth knowledge of Software Lifecycle Processes, including expertise in implementing the requirements of the IEC 62304 standard and AAMI TIR45 guidance.
- Communication Skills: Experience in communication with authorities and notified bodies.
- Collaboration Skills: Ability to collaborate effectively with internal specialists and other external consultants.
- Language Skills: Fluency in English is a requirement, German is a huge plus.
We are a developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform medical images, clinical workflows, and medical education into an interactive 3D mixed reality environment.
We are dedicated to revolutionizing the healthcare industry by leveraging cutting-edge technology and innovative solutions. Our team is multicultural and international, with over 10 countries represented in our office. We offer a flat hierarchy with direct access to the founding team and C-Level, high degree of ownership, and competitive compensation structure.
